4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 A randomised controlled trial of 222 patients with varicose veins treated by cyanoacrylate glue occlusion or radiofrequency ablation reported closure rates of 100% and 86% respectively at 1‑month follow‑up (p<0.01; absolute numbers not reported). A case series of 38 patients treated by cyanoacrylate glue occlusion reported complete closure of the great saphenous vein in 100% (38/38) of patients at 48‑hour follow‑up (diagnosed by duplex ultrasound imaging). The closure rates at 12‑ and 24‑month follow‑up were 92%; there were 2 partial recanalisations and 1 complete recanalisation. A case series of 70 patients reported that 93% (63/68) of patients were free from recanalisation at 12‑month follow‑up. A case series of 65 saphenous vein procedures (43 great saphenous veins and 22 small saphenous veins) reported a closure rate of 99% at 3‑month follow‑up (absolute numbers not reported).

4.2 The randomised controlled trial of 222 patients reported an improvement in the Venous Clinical Severity Score of approximately 3.5 points from baseline at 3‑month follow‑up (p<0.01), with no differences between the 2 treatment groups (cyanoacrylate glue occlusion or radiofrequency ablation). The case series of 38 patients treated by cyanoacrylate glue occlusion reported an improvement in the mean Venous Clinical Severity Score from 6.1 at baseline to 1.5 at 12‑month follow‑up (n=36, p<0.001). At 6‑ and 24‑month follow‑up, 84% and 65% of legs respectively had no oedema, compared with 39% of legs before treatment (absolute numbers not reported). Before treatment, all legs showed clinically relevant varicosities. At 12‑ and 24‑month follow‑up, 50% and 35% of legs were free from varicosities respectively (absolute numbers not reported). In the same study, the proportion of patients free from pain increased from 13% at baseline to 84% at 6‑month follow‑up and 64% at 24‑month follow‑up (absolute numbers not reported). The case series of 70 patients reported an improvement in the mean Venous Clinical Severity Score from 4.3 at baseline to 1.1 at 12‑month follow‑up (p<0.0001).

4.3 The specialist advisers listed key efficacy outcomes as complete closure of great/small saphenous vein (on duplex ultrasound), absence of long‑term recanalisation, improvement in leg symptoms, improvement in quality of life and patient satisfaction.

  • National Institute for Health and Care Excellence (NICE)